Class II U.S. Food and Drug Administration

Mazor X robotic guidance system REF: TPL0059 recall: Software errors that can result in incorrect surgical instrument positioning

Recall published 9 months ago

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1122-2026
Published
January 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Mazor Robotics Ltd
Product type
Medical devices
Units affected
549 systems
Distribution
Nationwide
Made in
Israel
Lot / code info
Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895
UPC codes
07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895

Products covered by this recall

Mazor X robotic guidance system REF: TPL0059

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07290109180465
  • 07290109184524
  • 07290109181158
  • 00763000635169
  • 07290109183213
  • 07290109184517
  • 00763000419134
  • 00763000431761
  • 07290109184098
  • 07290109184838
  • 07290115751376
  • 07290115751895

Model or item number

On the rating label, the box or the instruction sheet.

  • TPL0059 — Software versions

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Mazor Robotics Ltd — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Mazor Robotics Ltd — North Industrial Park, Caesarea

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Mazor Robotics Ltd medical devices recalled?

Software errors that can result in incorrect surgical instrument positioning during spinal surgery. Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07290109180465, 07290109184524, 07290109181158; model number TPL0059 — Software versions. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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